A study to Compare the Pharmacokinetics (PK) of Depemokimab When Delivered with a Safety Syringe Device (SSD) or an Autoinjector in Healthy Adult Participants
Trial overview
Maximum observed plasma concentration (Cmax) of depemokimab
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Area under the concentration-time curve from time zero extrapolated to infinity (AUC[0-inf]) of depemokimab
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Area under the concentration-time curve from time zero to time of last observed quantifiable concentration (AUC[0-t]) of depemokimab
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Time to maximum observed plasma concentration (Tmax) of depemokimab
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Apparent clearance following extravascular administration (CL/F) of depemokimab
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Apparent volume of distribution following extravascular administration (Vd/F) of depemokimab
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Terminal elimination rate constant (lambda z) of depemokimab
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Terminal Elimination Half-Life (T1/2) Following Administration of depemokimab
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Time of last measurable plasma concentrations (Tlast) of depemokimab
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Percentage of AUC (0-Inf) due to extrapolation from the time of the last observed concentration (tlast) to infinity (%AUCex) of depemokimab
Timeframe: Day 1: Pre-dose and 2, 8 hours post-dose; Days 2, 3, 5, 8, 15, 29, 57, 85, 127, 169 and 183 post-dose
Number of participants with presence of positive anti-depemokimab antibodies
Timeframe: Baseline (Day 1), Weeks 4, 8, 12 and 26
Number of participants with positive neutralizing antibodies to depemokimab
Timeframe: Baseline (Day 1), Weeks 4, 8, 12 and 26
Participation criteria
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram results.
- Body weight greater than or equal to (>=) 50 kilograms (kg) (110 pounds-mass/Ibs) and body mass index within the range 19 to 30 kg per meter square (inclusive).
- History or presence of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention, or interfering with the interpretation of data.
- Participants with allergy/intolerance to a monoclonal antibody or biologic or participants with a previous history of clinically significant multiple or severe drug allergies/intolerance.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, vital sign measurements, and 12-lead electrocardiogram results.
- Body weight greater than or equal to (>=) 50 kilograms (kg) (110 pounds-mass/Ibs) and body mass index within the range 19 to 30 kg per meter square (inclusive).
- Women who have the potential to become pregnant must use a form of highly-effective contraception.
- Capable of giving signed informed consent.
- History or presence of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, constituting a risk when taking the study intervention, or interfering with the interpretation of data.
- Participants with allergy/intolerance to a monoclonal antibody or biologic or participants with a previous history of clinically significant multiple or severe drug allergies/intolerance.
- Current evidence or recent history of an infective illness.
- A positive pre-study drug/alcohol screen or a history (or suspected history) of alcohol misuse or substance abuse
- Clinically significant abnormalities.
- Positive test for severe acute respiratory syndrome coronavirus (SARS-CoV-2) at screening.
- Recent prior or concurrent clinical study experience.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
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